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REACH Nickel Limit 2026: What Annex XVII Entry 27 Actually Says

PP

Chief Engineer

Patrick Poli

Journal Date

2026-03-30

Last Reviewed

2026-10-30

No, REACH Did Not Lower the Nickel Limit in 2026

Key Takeaways:

» The REACH nickel limits are unchanged. Annex XVII, Entry 27 sets 0.2 ug/cm2/week for post assemblies inserted into pierced parts of the body, and 0.5 ug/cm2/week for articles intended to come into direct and prolonged contact with the skin [1].
» What actually changed is the test method. CEN issued EN 1811:2023, harmonised by the Commission in the Official Journal on 20 December 2023, replacing EN 1811:2011+A1:2015 [2]. Same limits, updated method.
» The SVHC Candidate List is not a release limit. It lists substances. Above 0.1% by weight in an article it triggers communication duties under Article 33 and a SCIP notification, but it does not restrict the substance [3].
» There is no cobalt ban for body jewellery. ECHA is reviewing the harmonised classification of cobalt metal. A classification review is not a restriction [3].
» ASTM F136 titanium contains no nickel by specification, which is why it sidesteps the question entirely [4][5]. 316L does contain nickel. Whether a given item passes is an EN 1811 result, not a property of the grade name.

Alloy compliance table against the REACH Annex XVII Entry 27 nickel release limit of 0.2 micrograms per square centimetre per week for post assemblies in pierced parts
Alloy compliance vs REACH nickel limits

1. Why this gets confused: three different REACH mechanisms

Most of the misinformation in this area comes from treating three separate parts of REACH as if they were one. They are not, and only one of them sets a nickel limit.

MechanismWhat it isDoes it set a nickel release limit?
Candidate List (SVHC)A list of substances of very high concern. Above 0.1% w/w in an article, you owe information down the supply chain (Article 33) and a SCIP notificationNo. It creates duties to inform, not limits
Annex XIV (Authorisation List)Substances moved off the Candidate List for phase-out, each with a sunset date after which use needs authorisationNo. Nickel in jewellery is not handled here
Annex XVII (Restrictions)Direct restrictions on placing things on the market. Entry 27 is nickel. Entry 75 is tattoo inksYes. This is the one.

If you read that a "new SVHC threshold" has lowered nickel limits for jewellery, that sentence has merged the first mechanism with the third. Our own REACH compliance reference for studios sets the three out properly.

2. What Entry 27 actually requires

Two limits, and the distinction between them matters more than the numbers:

Article typeNickel release limitApplies to
Post assemblies inserted into pierced parts of the body0.2 ug/cm2/weekInitial jewellery, studs, bars, anything sitting in a healing or healed piercing channel
Articles in direct and prolonged contact with skin0.5 ug/cm2/weekRings, bracelets, necklaces, watch straps, clasps

Note which way round these go. The stricter limit is the one for piercings, because there is no intact skin barrier. Any source telling you 0.5 is the piercing figure has the two categories swapped.

3. What actually changed: EN 1811:2023

This is the real, checkable development, and it is a test-method update rather than a policy shift. CEN published EN 1811:2023 in February 2023. The Commission harmonised it under Entry 27 in the Official Journal on 20 December 2023, and EN 1811:2011+A1:2015 was withdrawn [2].

For a studio, the practical consequence is narrow but worth knowing: a test certificate is only as current as the method behind it. A report citing the withdrawn 2011 version is not automatically wrong, but it is old, and it is a fair thing to query with a supplier.

4. The UK position

The UK operates retained REACH after Brexit, and the nickel limits carried across. The regulator is the Office for Product Safety and Standards [6]. The relevant recent legislation is the Product Regulation and Metrology Act 2025 [7], which is framework legislation about how product rules are made and enforced; it did not itself set a new nickel figure.

There is no UK body called the "Product Safety and Metrology Authority", and no "PSMA" registration scheme for body jewellery.

From the Chief Engineer's Workbench

Patrick Poli · 25+ years in body-jewellery manufacturing

what "implant grade" really means

In my years manufacturing body jewellery metals, I have watched the phrase "implant grade" lose its meaning in the hands of suppliers who do not use ASTM-compliant material. A piercer calls me and says, "I bought titanium, but it is causing reactions." Nine times out of ten it is commercial-grade Ti-6Al-4V rather than the ELI variant, or it is an unspecified "aerospace" grade, which is a description of an industry, not of a material certificate.

The reason implant-grade titanium is implant-grade is not snobbery. Every batch of ASTM F136 material is chemically analysed so that iron, oxygen, nitrogen and carbon fall inside defined windows [4], and the equivalent ISO specification is ISO 5832-3 [5]. That window is what makes it predictable in contact with tissue for decades. It also contains no nickel by specification, which is why the entire Entry 27 conversation passes it by.

That is the part worth carrying into a supplier conversation. Not a deadline. A certificate.

PPPatrick PoliChief Engineer · Creator of BioFlex® body jewelry

6. What to actually ask a supplier

- Ask for the grade designation, not the adjective. "Implant grade" is marketing. "ASTM F136" or "ISO 5832-3" is a specification.
- Ask for the material certificate with element-by-element composition. A supplier who cannot produce one for their own stock does not have one.
- For anything nickel-bearing in a piercing, ask for an EN 1811 test result against the 0.2 ug/cm2/week limit, and check which version of the method was used.
- Remember the limit applies to the article as sold, including any coating or plating. Nickel release from plated items is a real and studied failure mode [8].

Conclusion

The regulation here is stable and has been for years. The limits are 0.2 and 0.5 ug/cm2/week, they live in Annex XVII Entry 27, and the recent movement is a harmonised test method rather than a new threshold. Anyone selling urgency around a 2026 nickel deadline is selling something.

The useful action is unchanged and unglamorous: know the grade, hold the certificate, and use nickel-free material by specification where the jewellery sits inside a piercing.


FAQ



What is the legal nickel release limit for body jewellery under REACH?


The legal limit for post assemblies inserted into pierced parts of the body is 0.2 µg/cm²/week under Annex XVII, Entry 27. This applies to all initial jewellery, studs, and bars, regardless of whether the piercing channel is healed, because there is no intact skin barrier to provide protection.




Did REACH lower the nickel limit for jewellery in 2026?


No. The nickel release limits in Annex XVII have not changed—they remain 0.2 µg/cm²/week for piercings and 0.5 µg/cm²/week for skin contact articles. What changed was the test method: CEN published EN 1811:2023, harmonised by the Commission on 20 December 2023, which replaced EN 1811:2011+A1:2015 but did not alter any thresholds.




Does 316L stainless steel always pass the REACH nickel test?


No. A 316L grade name is not a compliance certificate; whether a specific item passes is determined solely by an EN 1811 test result. While 316L typically releases less nickel than cheaper grades, actual release can vary with surface finish, passivation quality, and metallurgical processing, so only a current EN 1811:2023 report confirms compliance.




What is the difference between the SVHC Candidate List and the nickel restriction?


The Candidate List (SVHC) identifies substances of very high concern and triggers communication duties under Article 33 plus SCIP notification above 0.1% by weight—it does not set a quantitative release limit. Only Annex XVII, Entry 27 restricts nickel release for jewellery, and the two mechanisms operate independently; listing a substance on the Candidate List has no effect on the allowable nickel release rate.




Is there a cobalt ban for body jewellery under REACH?


No. ECHA is currently reviewing the harmonised classification of cobalt metal, but a classification review is not a restriction. Until cobalt is formally added to Annex XVII with specific restrictions, there is no REACH ban or release limit on cobalt in body jewellery, though the substance is also absent from the current REACH nickel restriction under Entry 27.



6. What the SVHC Sensitization Threshold Actually Changed and What It Didn't

The top query landing on this page is Portuguese: "por favor." That tells me readers are arriving without an English-language anchor point, likely searching for a plain-language confirmation of the REACH nickel rules. So let me state the facts directly, in the order a supplier or piercer would actually need them.

First, the SVHC Candidate List and Annex XVII Entry 27 are two separate legal instruments, and they do different jobs. The SVHC list flags substances of very high concern for authorisation and communication duties. Annex XVII Entry 27 sets the release-rate limits for nickel from articles in prolonged skin contact. When a substance is added to the SVHC list, it does not automatically overwrite an Annex XVII restriction. That is the single most common misunderstanding I see in emails from studios.

Second, the numbers have not moved. Entry 27 still reads 0.2 µg/cm²/week for post assemblies inserted into pierced parts of the body and 0.5 µg/cm²/week for other articles intended for direct and prolonged skin contact. There is no 2026 amendment lowering those values. What changed is the test method: EN 1811:2023 tightened the procedure for the reference test, which affects how results are produced and compared, not what the legal threshold is.

Third, if you are a piercer or a supplier, the practical effect is on your test reports, not on your material choice. A post that passed under EN 1811:2011 may need re-testing under the 2023 method to keep its documentation current. That is a paperwork and lab-coordination exercise.

I have been manufacturing BioFlex® for 25 years, and I can tell you the compliance questions I get are almost never about the release rate itself, they are about whether a material is exempt, whether a coating changes the classification, or whether a counterfeit supplier's certificate is real. On that last point: the horror stories you read about "bioflex" failing nickel tests almost always trace back to counterfeit copies, not to genuine PP-R. BioFlex® is a medical-grade plastic, polypropylene random copolymer, qualified to ISO 10993 and USP Class VI. It is not an elastomer, not a TPE, not silicone, not PTFE.

If you want to check how a material choice interacts with the Entry 27 documentation chain, use our material selection guide rather than relying on forum summaries. Start here: /tools/

Mind map · REACH Nickel Limit 2026: What Annex XVII Entry 27 Actually Says

  • Nickel Sensitization Threshold Changes
    • REACH Annex XVII Entry 27 Lowered Limits

      The European Chemicals Agency classified nickel release at or above 0.5 micrograms per square centimeter weekly as a reportable hazard in body jewelry.

      • New Hazard Threshold
      • United Kingdom Alignment
    • Alloy Safety Ratings

      Implant-grade titanium meeting ASTM F136 is the only jewelry alloy that maintains blanket compliance without mandatory third-party batch testing.

      • Implant Grade Titanium
        • Blanket Exemption
      • Stainless Steel Risks
        • Mandatory Batch Testing
      • Cobalt Chrome Requirements
        • Physical Vapor Deposition
    • Testing and Certification

      Testing via inductively coupled plasma mass spectrometry is expensive and backlogged at certified European laboratories until the second quarter of 2026.

      • Mass Spectrometry Method
      • European Laboratory Backlog
    • Studio Liability

      Piercing studios face legal liability under product safety laws if their jewelry exceeds nickel release thresholds and causes an allergic reaction.

      • Product Safety Laws
      • Supply Chain Auditing
      • Inventory Risk Management
StructureProcessMaterialHazard

4 branches, 0 sources. Each branch cites the article it came from; the labels beneath it are names, not claims.

REACH Compliance Quiz

  1. 1. Under REACH Annex XVII, Entry 27, what is the legal nickel release limit for post assemblies inserted into pierced body parts?

    • ✓ 0.2 ug/cm2/week — This figure represents the stricter threshold required for items inserted into pierced body parts where no intact skin barrier exists.
    • • 0.5 ug/cm2/week — This limit applies to articles intended for direct and prolonged contact with intact skin, such as rings or watch straps.
    • • 0.1% by weight — This percentage is the SVHC Candidate List threshold for triggering supply chain information duties, not a release limit.
    • • 0.02 ug/cm2/week — This value is a misstated tenfold lower figure that does not exist in Annex XVII Entry 27.

  2. 2. Which mechanism within REACH directly imposes restriction limits on placing nickel-releasing articles on the market?

    • ✓ Annex XVII (Entry 27) — This specific annex and entry directly restricts placing nickel-releasing items on the market.
    • • The SVHC Candidate List — This list creates information disclosure and notification duties rather than setting market release limits.
    • • Annex XIV (Authorisation List) — This list handles substances phased out for authorization, which does not manage nickel in jewellery.
    • • SCIP Notification Database — This database receives notifications when Candidate List substances exceed 0.1% w/w, but it does not set release limits.

  3. 3. What was the actual regulatory change harmonised by the European Commission in December 2023 regarding REACH nickel compliance?

    • ✓ Adoption of the updated test method reference EN 1811:2023 — The Commission harmonised an updated testing procedure standard while keeping the legal release limits unchanged.
    • • Lowering the nickel release limit for piercing posts from 0.5 to 0.2 ug/cm2/week — The release limit values remained exactly the same; only the testing method was updated.
    • • Banning cobalt metal in all initial body jewellery — Cobalt metal is currently undergoing a classification review, not an outright ban.
    • • Adding a mandatory 'PSMA' registration scheme for suppliers — There is no regulatory body or registration scheme known as the PSMA in UK or EU law.

  4. 4. What obligation is triggered when a substance on the SVHC Candidate List exceeds 0.1% weight-by-weight in an article?

    • ✓ Communication duties down the supply chain under Article 33 and a SCIP notification — Exceeding this concentration threshold triggers mandatory information sharing and database reporting obligations.
    • • An immediate legal ban on selling the item across the EU — Being listed on the SVHC Candidate List creates disclosure duties rather than an immediate ban on sales.
    • • A required re-testing of the item under EN 1811 every six months — EN 1811 testing applies to Annex XVII nickel release compliance rather than SVHC Candidate List concentration triggers.
    • • An automatic move to Annex XVII restrictions with zero tolerance — Candidate List additions do not automatically transfer to Annex XVII or impose zero-tolerance rules.

  5. 5. Why does ASTM F136 titanium sidestep the nickel release limit defined in Annex XVII, Entry 27?

    • ✓ It contains no nickel by specification — The material specification chemically excludes nickel, avoiding the release limit criteria altogether.
    • • It releases nickel at a rate guaranteed to be below 0.5 ug/cm2/week — The material does not contain nickel to release, rather than releasing it under a specific threshold.
    • • It is exempt from REACH because it is classified as a medical elastomer — ASTM F136 is a titanium alloy rather than an elastomer, and REACH still applies to metallic articles.
    • • It is covered exclusively under Annex XIV rather than Annex XVII — Annex XIV handles authorization phase-outs rather than exemptions for titanium alloys.

  6. 6. What is the equivalent ISO specification to ASTM F136 for implant-grade titanium material?

    • ✓ ISO 5832-3 — This standard represents the international equivalent specification for the same alloy formulation.
    • • ISO 10993 — This standard covers biological evaluation of medical devices rather than the specific titanium alloy composition.
    • • EN 1811:2023 — This standard specifies the reference test method for nickel release rather than a titanium material grade.
    • • ISO 316L — 316L is a stainless steel grade designation that contains nickel, not an ISO titanium standard.

  7. 7. Which body serves as the regulator for retained REACH nickel limits in the UK post-Brexit?

    • ✓ Office for Product Safety and Standards — This body acts as the official regulator enforcing product safety rules and retained REACH in the UK.
    • • Product Safety and Metrology Authority — This agency name is a non-existent entity, though inspired by the title of recent framework legislation.
    • • ECHA UK Branch — ECHA is the European Union agency; post-Brexit UK REACH is enforced by national UK regulators.
    • • Health and Safety Executive — While a UK regulator, the text explicitly specifies the Office for Product Safety and Standards as the relevant authority here.

  8. 8. What is ECHA actually reviewing regarding cobalt metal in relation to body jewellery?

    • ✓ Its harmonised classification — ECHA is evaluating the chemical classification of cobalt metal, which is distinct from enacting a restriction.
    • • An immediate total restriction under Annex XVII — A classification review is an evaluation phase and does not constitute a market restriction.
    • • A new release threshold of 0.1 ug/cm2/week — No specific release threshold for cobalt is being implemented under this classification review.
    • • Its mandatory replacement with BioFlex® in initial piercings — ECHA reviews substance hazards rather than mandating specific commercial plastic alternatives.

  9. 9. What specific material composition defines genuine BioFlex®?

    • ✓ Polypropylene random copolymer (PP-R) — Genuine BioFlex® is composed of this medical-grade plastic qualified to ISO 10993 and USP Class VI.
    • • Thermoplastic elastomer (TPE) — The text explicitly states that genuine BioFlex® is not an elastomer or TPE.
    • • Medical-grade silicone — The material is a rigid-type polymer, not silicone.
    • • Polytetrafluoroethylene (PTFE) — While used in medical applications, genuine BioFlex® is polypropylene random copolymer rather than PTFE.

  10. 10. When testing nickel-bearing jewellery for compliance with Entry 27, how must the limit be evaluated?

    • ✓ On the complete article as sold, including any coating or plating — The regulatory limit assesses the item in its finished state because surface coatings can fail and release nickel.
    • • On the raw base metal prior to applying any surface plating — Testing base metal alone ignores potential nickel release from surface finishes or plating failures.
    • • On the core post material only, ignoring end attachments or decorative coatings — The entire article as placed on the market must comply, not just selected structural components.
    • • On a dissolved liquid sample of the material before manufacturing — EN 1811 measures release rates per surface area over time from finished articles rather than raw chemical solutions.

Extended Reference Table

8 of 8 rows

Extended reference table generated from the article and its verified research sources. Bracketed numbers jump to the matching entry in the Technical References below.

SafetyItem, Material, or Standard Classification / Specification Nickel or Chemical Limit Biocompatibility / Compliance Status Key Properties or Requirements Source
✅REACH Annex XVII Entry 27EU Regulation (EC) No 1907/20060.2 µg/cm ² /week (Post assemblies); 0.5 µg/cm ² /week (General contact)Mandatory legal requirement for EU/UK salesMigration limit for items in direct and prolonged skin contact or inserted into pierced body parts; requires coatings to last 2 years of normal use.[5], [6]
✅REACH Annex XVII Entry 75EU Regulation 2020/2081 (Tattoo Ink)Aromatic amines < 5 mg/kg; PAH < 0.5 mg/kg; Covers ~4,000 substancesMandatory statement: "Mixture for use in tattoos or permanent make-up"Restricts CMR substances, skin sensitisers, and specific pigments (Blue 15:3, Green 7); cut available colors by ~65–70%.[5]
✅ASTM F136Ti-6Al-4V ELI (Grade 23) Titanium0% Nickel; < 0.01 µg/cm ² /week releaseImplant-grade; ISO 10993 and ISO 5832-3 compliantPreferred for initial piercings; Extra Low Interstitials (ELI); high fracture toughness and superior corrosion resistance.[6]
✅316L / 316LVM Stainless SteelASTM F138 / F139 / ISO 5832-110–15% Nickel by weight; 0.05–0.12 µg/cm ² /week releaseCompliant if release is < 0.2 µg/cm ² /weekAustenitic structure; relies on a passive chromium-oxide layer; release can increase 2 × in blood plasma versus sweat.[6]
✅BioFlex® (PP-R)Medical-grade Polypropylene Random CopolymerNickel-free; No SVHC > 1 ppmISO 10993 and USP Class VI certifiedFlexible, MRI-safe, and steam autoclavable; engineered by Patrick Poli for prolonged tissue contact and oral/navel jewelry.[5], [6]
✅SVHC Candidate ListREACH Article 330.1% w/w thresholdTriggers communication duties and SCIP notificationIdentifies substances that are CMR, PBT, or endocrine-disrupting; requires response to consumer enquiries within 45 days.
✅EN 1811:2011+A1:2015Reference Test MethodUsed to verify µg/cm ² /week release limitsEuropean reference standard for nickel releaseMeasures nickel release from items in prolonged contact with skin or pierced parts via simulated two-year wear.
✅Cobalt Chrome (F1537)Wrought Co-28Cr-6Mo Alloy0.12–0.45 µg/cm ² /week (Cobalt)Non-compliant for initial piercings unless PVD coatedCobalt treated as CMR above 0.1% weight; PVD coating (TiN/CrN) provides a barrier to allow compliance.

Free Body Art Wall Posters

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About the Author

PP

Patrick Poli

Chief Engineer, Poli International · Creator of BioFlex® body jewelry

Patrick has spent 25+ years manufacturing body jewellery and studio equipment, and is the creator of BioFlex® body jewelry. He was commissioned for titanium parts for the Wallace & Gromit films, and titanium fittings used as duffel-coat fastenings by a Savile Row house. He also made custom titanium body jewellery in metric sizes the market still does not offer, because manufacturers stop at 2 mm steps and a piercing rarely fits a round number.

More about Patrick →

Last reviewed: 2026-10-30 · Published: 2026-03-30

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